The aim of this study was to assess the reasons why patients in the ED refused to participate in a palliative care, randomized controlled trial. The most common patient refusal reasons were barriers related to 1) the severity of the patient’s illness, 2) misconceptions or stigma related to palliative care, and 3) the mode of palliative care delivery. Barriers including illness severity, misconceptions and family/caregiver and physician gatekeeping are previously cited in the literature, but the mode of palliative care delivery is a finding that is unique to this study. We hypothesized that family/caregiver and physician gatekeeping would be a more prevalent refusal reason and barrier, but we found these to be far less common in our study. Thus, our findings provide insights into ways in which researchers can tailor recruitment strategies as well as design palliative care programs which meet the needs of this patient population.
Aligning with lessons learned from the Principal Investigator’s prior randomized controlled trial of Palliative Care in ED, our enrollment goal was 50% and overall enrollment rate was 45% across the eleven sites.21–23 Despite being slightly under our target goal, the data we have collected thus far provide valuable lessons learned for future research in this field. As it is well documented that research within palliative care populations is difficult, this enrollment rate is not particularly surprising.12,23,34 The FamCope Trial, which aimed to test the feasibility of nurse-led, family-coping-oriented palliative home care in patients with advanced cancer, encountered higher refusal rates in comparison to our study (66% vs. 55%) but cited some similar reasons for refusal such as a “lack of energy” or being “too sick.”7 In contrast to the FamCope Trial, our study found that patients often declined to participate because they felt that they were satisfied with their current care. Although this is not a frequently reported barrier in the literature, other studies also have reported that patients with advanced cancer often refuse to participate in palliative research due to satisfaction with their current care.14 Presumably, there are some patients with advanced illness whose needs are being met with their current care, and thus do not feel as though they would benefit from palliative care.
To date, research suggests that some providers still hold perceptions that palliative care is only appropriate at the end of life.10 Although other studies have cited this as a barrier, we did not find physician or family/caregiver gatekeeping to be a major recruitment barrier within our study.11,23 We believe the rationale of why physicians were not a barrier is because the last several years have brought about a shift of attitude toward palliative care within the healthcare community. Recent studies have found physicians have a greater understanding of the role of palliative care and are more confident in referring patients to palliative care services.24,25 Physicians were given the opportunity to opt-out their patients in the EMPallA study prior to recruitment, but few took the study team up on the offer. Additionally, a recent study analyzing the perceptions of palliative care among healthcare providers before and after implementation of a palliative medicine division found increased attendance in educational activities and increased confidence in palliative care.25 Within the same study, providers who favored co-management with palliative care held core values that aligned with current concepts, such as advanced care planning.25 We expect that as the number of palliative care programs in hospitals across the country increases, understanding and acceptance of palliative care amongst providers will continue to grow and foster a new set of beliefs and norms.26 Our results also demonstrated that family and caregivers did not impede recruitment. We hypothesize they did not hinder the recruitment process, as research coordinators anecdotally expressed many patients were often alone in the ED when approached. More detailed data collection is needed to understand this concept more deeply.
In regard to the perceptions of our patient population, patients refused participation as they held preconceived notions that to enroll in palliative care implied that they were giving up or were ready to die. These notions were rarely alleviated despite research coordinators’ explanations that palliative care would not and should not replace current treatment. Other studies have reported similar barriers to recruitment, with patients often associating palliative care with hospice or death.7,14
This study also further demonstrates that the mode of palliative care delivery often factored into a patient’s decision to participate in the study. Of the patients who did not participate due to mode of palliative care delivery, the majority indicated that they did not want to be randomized into the outpatient palliative care arm, due to inability or unwillingness to make it to in-person clinic visits. In contrast, relatively few patients said that they did not want to receive telephonic care. This finding is noteworthy for future researchers and healthcare system leadership as it demonstrates that patients may be more open to receiving palliative care if they do not have to attend in-person outpatient clinic visits. To our knowledge, these are new findings which have not been reported in other studies. Aligning with our results, these findings suggest that patients with advanced illness may be reluctant to add an additional in-person clinic appointment to their schedules, as they may be overburdened with multiple appointments. Telemedicine visits (e.g. phone call, video chat) may be a feasible alternative to in-person clinic visits, and other studies have demonstrated success of telephonic palliative care.27,28 Future studies should continue to explore the effectiveness of telehealth visits as an alternative mode of care delivery for this specific population.
Implications for Future Studies
The findings from this paper provide important lessons for future studies with palliative care populations, both in general and in the context of the ED. We suggest implementing a robust training infrastructure and documentation system for research coordinators. Creating a systematic and standardized approach can minimize bias and may increase fidelity of research coordinators. Training should include CTTI recruitment communication planning such as: developing a standard patient-centered script, shadowing senior research coordinators, supervised patient recruitment by senior research coordinators, proper documentation of each encounter, and ongoing supervision and oversight of all research coordinators by either the site project manager or principal investigator. Involving a palliative care physician in the training process is crucial, as they can provide important feedback regarding proper language and messaging techniques. For this population specifically, tailored messages should be developed so that both patients and their families understand that palliative care can provide an added layer of support and can be delivered in conjunction with life-prolonging treatment.
Prior to active recruitment, we recommend research coordinators role-play patient recruitment scenarios with patient stakeholder groups like the SAC in order to receive constructive feedback. The training infrastructure should be closely monitored. To minimize site variations in the context of our multi-site study, we conducted in-person site visits prior to launch, developed standard materials that could be personalized with site specific logos, and implemented weekly calls to discuss recruitment barriers and facilitators. Calls were also used to brainstorm strategies in overcoming recruitment barriers. All facilitators were disseminated to all sites enrolled in the study. As the NYU Research Team closely monitored and evaluated recruitment metrics as per the CTTI framework recommendation, high performing recruitment sites were paired with low performing sites to provide feedback and support.
More research is needed on how best to engage physicians to ensure they are allies, rather than barriers, in the recruitment process. We suggest providing physicians with the autonomy to exclude their patients, as we did within this study. Another suggestion could include engaging physician stakeholders during the development of the research project, as they likely hold unique perspectives on the best ways to recruit patients.
The major strength of this paper is the generalizability of the results across different geographic ED contexts (11 unique EDs across the country), thus demonstrating that it is feasible to recruit patients who have multiple disease etiologies into palliative care research studies. Understanding patient barriers within this sub-population is integral in order to plan and develop trials that leverage successful recruitment strategies. In addition to including patients from across the United States, our study included a broad patient population with multiple disease etiologies. While other palliative care studies are limited to patients with advanced cancer, our study recruited patients with advanced cancer, congestive heart failure, chronic kidney disease, and chronic obstructive pulmonary disease. By including these patients, we have captured a wider scope of patients with advanced illness and improved the generalizability of these findings. Furthermore, it is relatively uncommon for studies to record reasons for refusal. In the context of such a large study, these refusal reasons provide unique insight into the reasons why patients with advanced illnesses are hesitant to engage in palliative care research.
Our CONSORT diagram reveals that a significant portion of patients were deemed ineligible due to hospital admission. This posed a unique limitation to EMPallA, as we were unable to collect refusal data from patients admitted into the hospital. Nonetheless, this exclusion criterion was essential for our study design in order to target a specific group of patients who may not otherwise have access to palliative care programs. Notably, palliative care services are available to admitted patients, but few resources exist for patients who are discharged home from the ED.29–31
Furthermore, our study identified that family and caregiver gatekeeping was not a common barrier to enrollment in our patient population, but we are unable to draw definitive conclusions due to limited data collection specific to this refusal reason. In research, it is challenging to capture information and the rationale of non-participants; thus, future studies should try to incorporate qualitative methods such as content analyses in order to thoroughly interpret findings.